Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer
- Determine the benefits of radiotherapy schedules using fraction sizes larger than 2.0
Gy in terms of normal tissue responses, local-regional tumor control, quality of life,
and economic consequences in women prescribed postoperative radiotherapy for early
stage breast cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, type of surgery (mastectomy vs local excision), and breast boost (yes vs no).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50
- Arm II: Patients receive radiotherapy 5 times a week for 3 weeks for a total dose of 40
A breast boost is recommended in both arms for patients with microscopic evidence of
invasive or in situ cancer at, or within 1 mm of, a resection margin. These patients receive
radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy.
Quality of life is assessed at baseline and then at 6, 12, 24, and 60 months.
Patients are followed annually for up to 20 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1840 patients (920 per arm) will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
John R. Yarnold, MD, FRCR
Royal Marsden NHS Foundation Trust
United States: Federal Government